Apparatus for guiding an instrument used with an endoscope

ABSTRACT

An apparatus for guiding an instrument inserted through an endoscope&#39;s instrument channel is provided. The apparatus can attach to an endoscope to guide the position of the end of the instrument, such as by constraining the instrument to bend in a predetermined manner, or otherwise guide the distal end of the instrument extending from the distal end of the instrument channel. The apparatus can be used to assist in positioning the instrument to perform useful work on tissue adjacent the perimeter of the endoscope. The apparatus can also be used to provide cooperation between instruments inserted either through or alongside the endoscope.

This application is related to the following copending, concurrentlyfiled patent applications: application Ser. No. 09/541,371 “Method forControlling Position of Medical Instruments”; and application Ser. No.09/496,518 “Biopsy Forceps Device and Method” which are hearbyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to medical instruments, in general, and,more particularly, to a surgical device that can be used to position aflexible member of an instrument inserted into an endoscope.

BACKGROUND OF THE INVENTION

Physicians have often used endoscopes to examine, to biopsy, and toablate the tissue of patients within lumens such as the esophageous andthe bowel. These procedures include esophageal duodenoscopy, (EGD),colonoscopy, and polypectomy. Endoscopes used in these procedures can beseveral feet long and generally comprise one or more instrument channelsand optical fiber bundles. The instrument channels and optical fiberbundles open into the body at the distal end of the endoscope and aregenerally parallel to the axis of the flexible endoscope. Physiciansplace flexible instruments through the instrument channels whilevisualizing and illuminating a site using the optical fiber bundles. Theinstruments have end-effectors at the distal end for performing usefultherapeutic work to tissue. The instruments also provide at theirproximal ends operating mechanisms for actuating the end-effectors. Suchinstruments placed through an instrument channel of an endoscope mayinclude biopsy forceps for tissue sampling, electrical wires forradiofrequency ablation, or tubes used for irrigation, gas transfer,particular matter transfer, and suction.

A physician performing a therapeutic procedure with the use of anendoscope places a long, flexible instrument through the endoscope'sinstrument channel and then positions the instrument near the sitewithin the body lumen where a therapeutic procedure is to be performed.The physician grasps the endoscope with one hand and introduces theflexible instrument from an entrance at the proximal end of theendoscope with the other. An assistant usually holds the proximal end ofthe flexible instrument and operates the mechanism at the proximal endof the instrument to actuate the end-effector.

Locating the end-effector within the lumen presents difficulties to thephysician. The flexible instrument emerges from the instrument channelof the endoscope in a direction parallel to the axis of the endoscope.Many times work needs to be performed by the instrument at the innerwall of a body lumen, and at an angle to the axis of the endoscope. Muchtedious maneuvering of both endoscope and instrument is needed to placethe end-effector into a position to perform useful work. The flexiblenature of the instrument creates difficulties in locating theend-effector at the needed position on the inner wall of the body lumen.Rotating the endoscope to accommodate the instrument causes the image onthe monitor to rotate creating visualization difficulties for thephysician.

When the task to be performed is a biopsy, a tissue sample or specimenmust be transported away from the work site for collection. To collectthe specimen, the physician pulls the entire instrument from theendoscope, removes the specimen, places the specimen into a collectionjar, and replaces the instrument into the endoscope. The physician mustthen manipulate the instrument into a new position to take anotherspecimen.

SUMMARY OF THE INVENTION

Applicants have recognized the need for apparatus for facilitatingmanipulation of surgical instruments at the distal end of an endoscope.The apparatus can comprise a device, such as a mechanism, associatedwith the distal end of an endoscope. The mechanism guides the positionof a flexible instrument extending through or alongside the endoscope.In one embodiment, the mechanism can provide bending of a flexibleinstrument, while restricting twisting or other undesirable bending ofthe flexible instrument. In one embodiment, the mechanism can be used toprovide cooperative motion between multiple flexible instruments.

The mechanism can comprise a pivot arm associated with a base, the pivotarm and base together forming an end cap that is releasably joined tothe distal end of an endoscope. The pivot arm can engage a distal end ofthe instrument to constrain motion of the instrument, while permittingrotation of the distal end of the instrument. The pivot arm can providecurvature of the instrument, such as by bending, through an angle of atleast about 90 degrees, and in one embodiment through at least about 180degrees, while restricting twisting or other undesirable bending of theinstrument. The pivot arm can be used to position the end of theinstrument for performing work on tissue distal to and on the peripheryof the endoscope. The pivot arm can also be used with the endoscope toperform multiple biopsies without withdrawing the endoscope from thepatient's body. In one embodiment, the pivot arm can be used to providecooperative motion of a first flexible instrument extending through theendoscope and a second instrument that is insertable alongside theendoscope or within a second channel of the endoscope.

One or more flexible instruments may include an end-effector with asharp edge to cut tissue. One or more flexible instruments may include ahollow member to allow fluid, particulate, or gas to pass so thatsuction may be applied at the proximal end to retrieve tissue samples,or for providing a gas flow at a treatment site.

Additionally, the present invention may be used with or adapted torobotic assisted surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. The invention itself, however, both as toorganization and methods of operation, together with further objects andadvantages thereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is a view showing an end cap and biopsy forceps device accordingto an embodiment of the present invention assembled to an endoscopehaving associated videoscopic and pneumatic equipment.

FIG. 2 is an isometric view showing the distal end of the endoscope andassembly seen in FIG. 1.

FIG. 2A is a cross-section view taken through 2A—2A, showing a double-Dhole and a counterbore in a pivot-arm base.

FIG. 3 is an isometric view of the endoscope and assembly seen in FIG. 1with the interior flexible member extended and curved through aboutapproximately ninety degrees with respect to the endoscope.

FIG. 4 is an isometric view of the endoscope and assembly seen in FIG. 1with the interior flexible member extended and curved through aboutapproximately ninety degrees with respect to the endoscope and theexterior flexible member extended to cooperate with the interiorflexible member.

FIG. 5 is an isometric view of the endoscope and assembly seen in FIG. 1with the interior flexible member extended and curved through aboutapproximately one hundred eighty degrees with respect to the endoscopeand the exterior flexible member extended to cooperate with the interiorflexible member.

FIG. 6 is an isometric view of the endoscope and assembly seen in FIG. 1with the interior flexible member extended and curved through aboutapproximately one hundred eighty degrees with respect to the endoscopeand the exterior flexible member slightly retracted proximally from theposition shown in FIG. 5.

FIG. 7 is a side view of another embodiment of an end cap having abladed pivot arm utilizing an interior flexible member having suction topull tissue towards the blade.

FIG. 8 is a side view of the end cap of FIG. 7 with the interiorflexible member retracting to take a biopsy sample.

FIG. 9 is a side view of the end cap of FIG. 7 with the biopsy samplebeing evacuated away from the work area through the interior flexiblemember.

FIG. 10 is a side view of an embodiment of an end cap cooperating withan interior flexible member having a conductive wire through which RFcurrent may be applied with the flexible member curved through aboutapproximately ninety degrees with respect to the endoscope.

FIG. 11 is a side view of the end cap and flexible interior member ofFIG. 10 with the flexible interior member curved through aboutapproximately one hundred eighty degrees with respect to the endoscope.

FIG. 12 is a side view of an embodiment of an end cap with an interiorflexible member carrying a suture and thread and curved through an angleof about approximately ninety degrees with respect to the endoscope.

FIG. 13 is a side view of the end cap and interior flexible member ofFIG. 12 with the interior flexible member curved through an angle ofabout approximately one hundred eighty degrees with respect to theendoscope to suture tissue.

FIG. 14 is a side view of the end cap and interior flexible member ofFIG. 12 with the interior flexible member retracting.

FIG. 15 is a side view of an end cap and interior flexible member withthe interior flexible member having an inserted grasper.

FIG. 16 is a side view of the end cap of FIG. 15 showing the grasperpulling suture through tissue.

FIG. 17 is a side view of an embodiment of an end cap and an interiorflexible member equipped to emit ionized argon gas from a distal port.

FIG. 18 is a side view of an embodiment of an end cap and an interiorflexible member equipped to emit ionized argon gas from acircumferential port.

FIG. 19 is a side view of an embodiment of an end cap having a pivot armwith accordioning extensions.

FIG. 20 is a side view of the end cap of FIG. 19 showing the pivot armextended and the interior flexible member rotated through aboutapproximately ninety degrees with respect to the endoscope.

FIG. 21 is a side view of an embodiment of an end cap having a pivot armwith telescoping extensions.

FIG. 22 is a side view of the end cap of FIG. 21 showing the pivot armextended and the interior flexible member rotated through aboutapproximately ninety degrees with respect to the endoscope.

FIG. 23 is a side view showing an embodiment of an end cap attached to agrasper inserted through an instrument channel of an endoscope tocooperate with second grasper inserted through a second instrumentchannel of the endoscope.

FIG. 24 is a side view showing an embodiment of an end cap attached to agrasper inserted through an instrument channel of an endoscope tocooperate with second grasper inserted alongside the endoscope.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 depicts a suitable version of an endoscope 14 in combination withone embodiment of the present invention. A suitable version of endoscope14 can be the Olympus GIF-P140, and may be purchased from OlympusAmerica, Inc., in Melville, N.Y.

A control section 10 is located at the proximal end of endoscope 14. Agrip section 12 is on control section 10 for grasping of endoscope 14.Control section 10 also possesses a right/left angulation control knob16 and an up/down angulation control knob 18 for angulating the distalend of endoscope 14. A right/left angulation lock 20 and an up/downangulation lock 22 are provided to lock their respective knobs intoposition. Endoscope 14 may further provide an air/water valve 24 and asuction valve 26 attached to control section 10. Remote switches 28extend from control section 10. Remote switches 28 may be used tocontrol auxiliary equipment.

A boot 30 proceeds distally from control section 10. An instrumentchannel port 32 opens into boot 30 allowing introduction of instrumentsinto endoscope 14. The biopsy valve 34 seals instrument channel port 32.A narrow, flexible opening within biopsy valve 34 allows instruments topass while providing a gas-tight seal around the instruments. A valvecap 36 seals biopsy valve 34 when there is no instrument within theopening of biopsy valve 34.

The working length 44 extends distally from boot 30. Working length 44can be approximately a meter long, and has flexibility to move throughbody lumens such as the esophagus or lower intestines. An instrumentchannel 42 is open through the entire length of working length 44,opening proximally at instrument channel port 32. Fiber optics forillumination and visualization of the area distal to endoscope 14 alsoare within working length 44.

FIG. 1 shows universal cord 104 extending from grip section 12.Universal cord 104 carries fiber optics and a suction tube. A lightsource 106 for illuminating an area distal to the distal end ofendoscope 14 connects to endoscope 14 using fiber optics withinuniversal cord 104. Video monitor 110 connects through fiber opticswithin universal cord 104. Video monitor 110 may be controlled throughan attached video system center 111. Video monitor 110, light source106, and video system center 111 may be operable from remote switches 28and are used to view and photograph areas distal to endoscope 14. Asuction pump 108 is connected as well through universal cord 104 and isused to pull a vacuum through instrument channel 42. Suction pump 108has a collection jar 65 to receive tissue samples that have been pulledthrough instrument channel 42 by suction. Equipment such as suction pump108, light source 106, video monitor 110, and video system center 111may also be purchased through Olympus America, Inc., in Melville, N.Y.

FIG. 1 further depicts a biopsy forceps device 37 assembled to endoscope14. Biopsy forceps device 37 has an interior forceps half 50 and anexterior forceps half 56. Interior forceps half 50 provides a firsthandle 123 with a first plunger 38 at the end of an interior flexiblemember 58 to move interior flexible member 58 proximally and distally.Interior forceps half 50 is inserted into instrument channel port 32 andthrough instrument channel 42 within endoscope 14. Exterior forceps half56 provides a second handle 125 with a second plunger 62 to move anexterior flexible member 64 proximally and distally. Exterior forcepshalf 56 is located alongside endoscope 14 and may be held in place withattachment bands 40. Exterior flexible member 64 can move proximally anddistally through attachment bands 40.

Interior flexible member 58 and exterior flexible member 64 each can beprovided with a junction 67. Each junction 67 may have suction pump 108attached to pull a vacuum through interior flexible member 58 orexterior flexible member 64 to collection jar 65. Alternatively, eachjunction 67 may have an irrigation water supply attached to provideirrigation water. A plug 73 may be inserted into each junction 67, asshown in FIG. 1, to seal interior flexible member 58 and exteriorflexible member 64 when no external device is attached. It will beunderstood that while one exterior flexible member 64 is shown, two ormore external flexible members could be employed if desired.

FIG. 2 depicts the distal end of endoscope 14. Distal face 52 ispositioned at the distal end of endoscope 14 and provides associatedelements for visualization and medical therapy. Instrument channel 42opens at distal face 52 of endoscope 14. Light guide lenses 44, forallowing illumination of the work area, are also shown on distal face 52of endoscope 14. An objective lens 46, placed on distal face 52 ofendoscope 14, receives light from the work area and transmits an imageto video monitor 110 (FIG. 1). An air/water nozzle 48 is located at thedistal end of endoscope 14 adjacent to objective lens 46. Air/waternozzle 48 directs air and water onto objective lens 46 to defog andclean objective lens 46.

According to the present invention, a device, such as a mechanism, canbe associated with the distal end of the endoscope 14, the device forguiding a flexible instrument extending from an instrument channel inthe endoscope. As used herein, the term “mechanism” refers to deviceshaving one or more movable members, which members can be relativelyrigid or relatively flexible. Such mechanisms include, withoutlimitation: simple mechanical devices, such as linkages (e.g. single andmultiple link members wherein the links are pivotably connected to oneanother or a base, including four bar linkages, six bar linkages,linkages that include both hinged connections and sliding interfaces),as well as more complex mechanical devices such as telescoping devices,expanding scissors devices, devices which incorporate slidinginterfaces, ball and socket joints, universal joints, or other complexconnections between members.

According to one embodiment of the present invention, a pivot-arm base54 is disposed at the distal end of the endoscope 14, and can surroundthe distal end of endoscope 14. Pivot-arm base 54 can be releasablyjoined to the distal end of the endoscope 14, such as with a light pressfit, threaded engagement, snap fit, or by other suitable means.Pivot-arm base 54 can be releasably joined to the distal end of theendoscope 14 so that the pivot arm base 54 and its associated assemblycan be removed from the endoscope between operating procedures, such asfor cleaning, sterilization, addition of instruments, and the like.Alternatively, Pivot-arm base 54 can be fixedly attached to the distalend of the endoscope 14.

Pivot arm 74 connects to pivot-arm base 54 by, for example, pins placedthrough bosses 55 raised on pivot-arm base 54 and pivot arm 74 rotatesabout pivot axis 71. Pivot-arm stops 139 can be disposed on pivot arm 74to contact pivot-arm base 54 for limiting the angle through which pivotarm 74 rotates about axis 71. In the embodiment illustrated in FIG. 2, asubstantially rigid pivot arm 74 is shown having two curved supporthalves 77. Each support half 77 of pivot arm 74 extends from a proximalend 77 a adjacent axis 71 to a distal end 77 b. The distal ends 77 b canbe opposed as shown in FIG. 2. Each support half 77 can be shaped in anarcuate fashion to be curved away from the line of sight of objectivelens 46 to avoid obstructing the view seen by the physician throughobjective lens 46. A stepped-diameter pin 75 extends from the unattacheddistal end 77 b of each support half 77 of pivot arm 74, with the largerdiameter of each stepped-diameter pin 75 nearer support half 77 than thesmaller diameter. Guide tabs 113 can be located at the distal ends 77 bof support halves 77 adjacent stepped-diameter pins 75. Guide tabs 113can include longitudinal ramp surfaces 115 for positioning mating partslongitudinally, and radial ramp surfaces 117 for radially positioningmating parts, as described below.

Pivot arm 74 together with pivot-arm base 54 are illustrated in thefigures as end cap 82. End cap 82 comprising base 54 and pivot arm 74can be manufactured as a unit for assembly to endoscope 14. End cap 82can be reusable after sterilization, or alternatively, end cap 82 couldbe disposable. End cap 82 can be made from, for example, a plastic suchas polycarbonate or a metal such as stainless steel. Alternatively, amanufacturer of endoscope 14 could integrate pivot arm 74 with endoscope14.

End cap 82, comprising base 54 and pivot arm 74, can be provided insterile packaging. At the time of the medical procedure, the end cap 82can be removed from the sterile packaging and be joined to the distalend of the endoscope.

FIG. 2 further shows interior forceps half 50 proceeding from instrumentchannel 42. Interior forceps jaw 68 can attach to the end of interiorflexible member 58 by a press fit into the inner diameter of interiorflexible member 58. Interior forceps jaw 68 has a first sharp edge 70and two engagement holes 72 for insertion of the smaller diameter ofstepped-diameter pins 75. Interior forceps jaw 68 and interior flexiblemember 58 both have open interior portions, creating a hollow tubularstructure through which gas, fluids, particulate matter, or instrumentsmay pass through to the proximal end. Interior flexible member 58 mayhave a spring placed within the structure to support the walls ofinterior flexible member 58 while still allowing flexibility. Pivot arm74 as depicted in FIG. 2 is rigid enough to resist substantial unwanteddeflection caused by bending, torsion, and compression loading appliedby tissue and interior flexible member 58.

FIG. 2 further depicts pivot arm 74 connecting to interior forceps half50. In the embodiment shown in FIG. 2, pivot arm 74 has two connectedsupport halves 77 engaged with stepped-diameter pins 75 to interiorforceps jaw 68, capturing interior forceps jaw 68 to pivot arm 74.Stepped-diameter pins 75 align with each other, creating a first axis ofrotation 119. Interior forceps jaw 68 can rotate freely relative topivot arm 74 about first axis of rotation 119, but the rigidity of pivotarm 74 restricts rotation of interior forceps jaw 68 about thelongitudinal axis of interior forceps jaw 68.

FIG. 2 also shows the distal end of exterior forceps half 56 alignedalongside endoscope 14 and secured by pivot-arm base 54. Exteriorforceps half 56 possesses an exterior forceps jaw 76 affixed at thedistal end of exterior flexible member 64. Exterior forceps jaw 76 maybe attached, for example, by fashioning a connector portion 81 to extendproximally to press-fit into the inner diameter of exterior flexiblemember 64. Connector portion 81 has flats 83 on each side to engage adouble-D hole 87, depicted in cross-section in FIG. 2A, on pivot-armbase 54. Connector portion 81 can slide linearly through double-D hole87, but cannot rotate about the longitudinal axis of exterior forcepsjaw 76. Flats 83 on connector portion 81 abut the flat sides of double-Dhole 87 to resist such rotation. Exterior forceps jaw 76 and exteriorflexible member 64 are both open in their interior portions, creating atubular structure so that gas, fluids, particulate matter, orinstruments may pass through to the proximal end. Exterior flexiblemember 64 may also have a spring placed internally for support of theouter wall.

Exterior forceps jaw 76 provides a second sharp edge 78 and engagementnotches 80. Second sharp edge 78 is used with first sharp edge 70 fortissue cutting, and engagement notches 80 connect with the largerdiameters of stepped-diameter pins 75 to form a biopsy forceps as willbe described. Engagement notches 80 align with each other near thedistal end of exterior forceps jaw 76 to define a second axis ofrotation 121. Interior forceps jaw 68 rotates relative to exteriorforceps jaw 76 about second axis of rotation 121.

FIG. 3 further shows the distal end of endoscope 14 equipped with endcap 82 and biopsy forceps device 37. In FIG. 3, interior flexible member58 is seen extended and curved through about approximately ninetydegrees. To provide the assembly shown in FIG. 3, a physician or otheruse can first attach end cap 82 to the distal end of endoscope 14.Interior forceps half 50 can be inserted through instrument channel port32 (FIG. 1) and into instrument channel 42. At the distal end ofinstrument channel 42, pivot arm 74 can be connected to interior forcepsjaw 68 by insertion of the smaller diameters of stepped-diameter pins 75into engagement holes 72. Insertion of stepped-diameter pins 75 intoengagement holes 72 may be accomplished, for example, by spreadingsupport halves 77 and positioning engagement holes 72 of interiorforceps jaw 68 in between support halves 77. Support halves 77 may thenbe allowed to return back to their relaxed position to move the smallerdiameters of stepped-diameter pins 75 into engagement holes 72.Alternatively, stepped-diameter pins may be spring loaded, such as inthe fashion of watch band connection pins.

Exterior forceps half 56 is attached alongside endoscope 14 usingpivot-arm base 54. In the embodiment depicted in FIG. 3, exteriorforceps half 56 slips into double-D hole 87 from the distal side.Exterior flexible member 64, carrying proximally-attached second handle125, press-fits over connector portion 81 to complete the assembly ofexterior forceps half 56. Exterior forceps half 56 may be additionallysecured to endoscope 14 using attachment bands 40. Exterior flexiblemember 64 can be slipped through attachment bands 40.

Endoscope 14, end cap 82, and biopsy forceps device 37 are inserted intoa body near tissue to be examined or treated. The assembly may beinserted into, for example, a body lumen such as the esophagus or largeintestine.

After the device is inserted into the body, first plunger 38 (FIG. 1) isdepressed extending interior flexible member 58 through instrumentchannel 42. Pivot arm 74 restrains the distal end of interior flexiblemember 58 to travel substantially in an arc, curving interior forcepsjaw 68 towards a position distal to distal face 52 of endoscope 14 andon the outer periphery of endoscope 14. Pivot arm 74 substantiallyprevents twisting of interior flexible member 58 around the longitudinalaxis of interior flexible member 58. Pivot-arm stops 139 contactpivot-arm base 54 to prevent over-rotation of pivot arm 74. In theposition shown in FIG. 3, interior flexible member 58 and associatedforceps jaw 68 have moved substantially through an arc of aboutapproximately ninety degrees. Interior forceps jaw 68 is now in aposition visible through video monitor 110 (FIG. 1) utilizing lightreceived from objective lens 46. The physician may photograph the worksite using photographic equipment available with video system center111. The physician may also use computer equipment to process imagesreceived from the work site. The physician may maneuver interior forcepsjaw 68 to a position to take tissue, such as a polyp, from a biopsysite.

FIG. 4 shows exterior forceps jaw 76 extending from distal attachmentcollar 54. Second plunger 62 (FIG. 1) is depressed to move exteriorflexible member 64 and exterior forceps jaw 76 distally. As exteriorforceps jaw 76 extends distally from pivot-arm base 54, longitudinalramps 115 and radial ramps 117 effectively guide exterior forceps jaw 76into position to connect to stepped-diameter pins 75. Engagement notches80 on exterior forceps jaw 76 engage the larger diameter ofstepped-diameter pins 75, rotatably connecting interior forceps jaw 68to exterior forceps jaw 76. The two different diameters ofstepped-diameter pins 75 align, so that in the illustrated embodimentfirst axis of rotation 119 and second axis of rotation 121 coincide.First axis of rotation 119 of interior forceps jaw 68 about pivot arm 74and second axis of rotation 121 of interior forceps jaw 68 aboutexterior forceps jaw 76 lie on the same line. Accordingly, jaw 68rotates relative to jaw 76 about the same axis that jaw 68 rotates aboutpivot arm 74.

FIG. 5 shows interior forceps jaw 68 rotated into a closed position.First plunger 38 is depressed further to rotate interior flexible member58 and associated interior forceps jaw 68 through an additional ninetydegrees to about approximately one hundred eighty degrees of rotation.First sharp edge 70 and second sharp edge 78 can move past each otherand can take a biopsy sample in moving to the illustrated position.

Because exterior flexible member 64 has an open interior portion,suction pump 108 may be used through a junction open into exteriorforceps half 56 to apply suction through the exterior flexible member64. The biopsy sample or tissue sample can be suctioned away from thebiopsy site. The applied suction can pull a biopsy sample throughexterior flexible member 64 to the proximal end of endoscope 14 and outof endoscope 14. The biopsy sample may be suctioned into collection jar65 and taken for analysis. Alternatively, interior forceps half 50 coulduse collection jar 65 and attached suction pump 108 to collect biopsysamples as well. Suction may be applied from a junction 67 open into theproximal end of interior flexible member 58 to pull a biopsy samplethrough interior flexible member 58. Alternatively, an irrigationsolution such as water could be provided from the proximal end of one ofeither interior forceps half 50 or exterior forceps half 56 to flowthrough the loop created by the closed jaw halves. The flow ofirrigation solution could then force a tissue sample through the otherforceps half for collection.

These methods enable more than one tissue sample to be taken beforeremoving biopsy forceps device 37 from the body. Moving the sample awayfrom the biopsy site, such as by vacuum, frees biopsy forceps device 37to take another sample.

Features of pivot arm 74 make it useful for a variety of applications.First, pivot arm 74 can be used to constrain motion of the distal end ofinterior flexible member 58 to find predictably the same tissue area ofinterest. This useful attribute enables instruments intended tocooperate with interior flexible member 58, such as external forceps jaw76, to be repeatably placed at a tissue site that would normally bedifficult to repeatably access.

Second, pivot arm 74 can restrain motion of the distal end of interiorflexible member 58 along a predetermined path, such as along arc. In theembodiment shown, the distal end of the flexible member 58 can beconstrained in translation to cause interior flexible member 58 to curvethrough an arc of 90 degrees or greater to approach tissue spaced fromthe distal end of the endoscope and associated with the periphery ofendoscope 14 (such as is shown in FIG. 7). In particular, the pivot arm74 permits positioning of the distal end of the flexible member 58 at atissue site that is adjacent the distal end of the endoscope, yet offsetfrom the longitidunal axis of the endoscope a distance at least as greatas the radius of the endoscope. Accordingly, tissue sites adjacent thedistal end of the endoscope and associated with the perimeter of theendoscope can be accessed in a repeatable fashion.

Third, as illustrated in FIG. 5, the pivot arm can guide internalflexible member 58 to curve through an arc of about approximately 180degrees to face towards distal face 52 of endoscope 14. Guiding theinternal flexible member 58 to bend through an arc of about 180 degreesallows the distal end of flexible member 58 and any associated medicalinstrument to face the camera or other visualization device associatedwith the distal end of the endoscope. Accordingly, the user can morereadily view various aspects of treatment provided by the flexiblemember 58.

Fourth, because first axis of rotation 119 coincides with the secondaxis of rotation 121, the need for interior forceps jaw 68 to translaterelative to pivot arm 74 when cooperating with exterior forceps jaw 76is eliminated. Cooperative work can be accomplished by simple rotationof interior forceps jaw 68 once interior forceps jaw 68 is joined toexterior forceps jaw 76.

FIG. 6 illustrates exterior forceps jaw 76 and interior forceps jaw 68disengaged. After a biopsy sample has been taken, a physician movessecond plunger 62 (FIG. 1) proximally to retract exterior flexiblemember 64 and exterior forceps jaw 76 proximally to disengage exteriorforceps jaw 76 from interior forceps jaw 68. The physician also retractsinterior flexible member 58 by moving first plunger 38 (FIG. 1)proximally. Interior flexible member 58 moves through an arc as itretracts into instrument channel 42. Interior flexible member 58, usinginterior forceps jaw 68, rotates pivot arm 74 to return back to theposition parallel to distal face 52 of endoscope 14. The physician maywithdraw endoscope 14 from the patient, or the physician may chooseanother area of tissue within the patient to biopsy. The physician doesnot need to withdraw any portion of biopsy forceps device 37 from thebody before taking another specimen of tissue.

Different methods of tissue biopsy can be performed on tissue using endcap 82 attached to an interior flexible member 58. FIG. 7 shows anexample of a rigid pivot arm 74 equipped with a ring 98 containing ablade 100. The embodiment of pivot arm 74 shown in FIG. 7 is pivotallyattached to pivot-arm base 54. Pivot arm 74 of FIG. 7 is rigid enough toprevent substantial deflection caused by bending, torsion, andcompression loading applied by tissue and interior flexible member 58.Pivot arm 74 of FIG. 7 could be made of, for example, aluminum or anengineering plastic such as polycarbonate.

FIG. 7 further illustrates that blade 100 could fit substantially withinring 98 leaving an opening through which a tissue sample could pass.Interior flexible member 58 assembles to pivot arm 74 using, forexample, a press fit into an extension from ring 98. As illustrated inFIG. 7, interior flexible member 58 could be a tube through whichsuction may be applied. Blade 100 slants proximally towards interiorflexible member 58 to assist in cutting or tearing tissue for biopsy,and blade 100 possesses a knife edge 102.

FIG. 7 shows an embodiment of interior flexible member 58 attached toring 98 of pivot arm 74 and extended to a position adjacent a wall ofbody lumen 88. As shown in FIG. 7, the pivot arm 74 can providerepeatable positioning of the distal end of the flexible member 58 at atissue site that is adjacent the distal end of the endoscope, andradially offset from the longitudinal centerline of the endoscope adistance at least as great as the radius of the endoscope. Accordingly,the mechanism according to the present invention allows repeatableaccess to tissue sites on a body lumen wall adjacent the distal end ofthe endoscope.

Suction applied to interior flexible member 58 could pull tissue pastblade 100 and into ring 98. Pivot arm 74 can then be retracted, as shownin FIG. 8, by retracting interior flexible member 58 while suctioncontinues through interior flexible member 58. Retraction of pivot arm74 can cause tissue to pull on blade 100 against the proximal slant ofblade 100. Edge 102 of blade 100 can then cut and tear a tissue biopsysample to be retrieved by the suction applied through interior flexiblemember 58, as shown in FIG. 9. If needed, a slight proximal and distalmovement of endoscope 14 can help edge 102 cut and tear tissue to beremoved. Because the tissue sample has been evacuated away from thebiopsy site, another biopsy may then be performed without removinginterior flexible member 58 or endoscope 14 from the body.

It will be recognized that equivalent structures may be substituted forthe structures illustrated and described herein and that the describedembodiment of the invention is not the only structure which may beemployed to implement the claimed invention. As one example of anequivalent structure which may be used to implement an embodiment of thepresent invention, pivot arm 74 may be created from a flexible strandsuch as a suture, wire, or string. FIG. 10 shows two such strandsextending from interior flexible member 58 to connect with pivot-armbase 54 to create an equivalent structure of end cap 82. Tension in thestrands of the embodiment of pivot arm 74 shown in FIG. 10 restrainsinterior flexible member 58 to angulate towards tissue distal to and atthe periphery of endoscope 14. Additionally, because the embodiment ofpivot arm 14 depicted in FIG. 10 consists of two flexible strands undertension, interior flexible member 58 is placed at an apex of atriangular structure. The two strands under tension direct flexiblemember 58 to a specific point along the periphery of endoscope 14.

Other apparatus may be envisioned to substitute for end cap 82. Forexample, end cap 82 may comprise a base 54 or an equivalent structuresupporting an equivalent mechanism for pivot arm 74. For example, base54 may become a spring clamp held by spring force to endoscope 14 whilecarrying a four-bar linkage. The four-bar linkage, by way of furtherexample, can be a substitute mechanism for pivot arm 74 to maneuver orguide an instrument. A mechanism such as pivot arm 74 may attachdirectly to endoscope 14 without the use of a base or its equivalent,making the mechanism the entire apparatus for maneuvering or guiding aninstrument.

As a further example of equivalent structures that may be used toimplement the present invention, different end-effectors to performdifferent types of therapy on tissue are seen.

FIG. 10 and FIG. 11 show pivot arm 74 of end cap 82 attached to interiorflexible member 58 containing a coil spring 84. Interior flexible member58 may be transparent to allow visualization of coil spring 84. Anopening 86 in the wall of interior flexible member 58 exposes a portionof coil spring 84 to a side wall of a body lumen. Coil spring 84 canextend proximally through endoscope 14 to the proximal end where anattachment to a generator produces RF current. RF current may be appliedthrough coil spring 84 to a wall of the body lumen in a specific areadistal to endoscope 14 to cause ablation of tissue for therapeuticvalue. Alternatively, two insulated wires could be utilized to providebipolar RF current. The wires could end in electrodes placed at opening86.

FIGS. 12 through 14 show an example of suturing through the openinterior portion of an extended interior flexible member 58. Interiorflexible member 58 may be formed from a spring with a thin plasticsleeve covering. A needle 92 carrying suture 94 may be used throughinterior flexible member 58. A needle retainer 90 is fashioned at thedistal end of interior flexible member 58. Needle retainer 90 may be,for example, a small tube attached at the distal end of interiorflexible member 58 and having an interior diameter slightly smaller thanneedle 92. Needle 92 is secured within needle retainer 90 by thefriction of a press fit between needle 92 and needle retainer 90. Suture94 trails proximally through interior flexible member 58 to a useful andconvenient length. End cap 82 with pivot arm 74 is attached to thedistal end of endoscope 14.

A physician can attach suture 94 to needle 92, insert needle 92 intoneedle retainer 90 and extend suture 94 proximally through interiorflexible member 58. End cap 82 is then connected to the distal end ofendoscope 14, and pivot arm 74 joined with the distal end of interiorflexible member 58. Interior flexible member 58 extends and travelsthrough an arc while restrained at the distal end of pivot arm 74,carrying needle 92 to pierce the wall of body lumen 88 at a precisepoint. Needle 92 may be fashioned with a curvature designed to travelthrough the tissue of body lumen 88 and emerge at a point offset fromthe insertion point in a manner shown in FIGS. 12 through 14. Afterneedle 92 has looped through tissue, interior flexible member 58 can bewithdrawn to leave needle 92 within the tissue to the side of the lumen.

FIGS. 15 and 16 depict grasper 96 emerging from interior flexible member58. A suitable grasper 96 may be purchased from Microvasive Endoscopy,in Quincy, Mass. A physician may take grasper 96 and insert it throughinterior flexible member 58, grasp the end of needle 92, and pull suturethrough the opening created by the needle. To tie off the knot, aphysician may place a clip on the loose threads to secure the suture.

FIG. 17 shows an embodiment of a mechanism maneuvering an interiorflexible member 58 that can emit ionized argon gas 101 to facilitate theflow of electrical current. A distal opening 99 to emit ionized gas maybe at the distal end of flexible member 58 as shown in FIG. 17, or acircumferential opening 103 may be placed on a circumferential portionof flexible member 58 as shown in FIG. 18. Ionized argon gas 101 cancoagulate large areas of tissue in a non-contact technique. Afterendoscope 14 is advanced into a body lumen such as the esophagus, pivotarm 74 can bend interior flexible member 58 to a point near, but nottouching, the inner surface of the body lumen. A sufficient voltage isthen placed across electrodes to ionize argon gas 101 proceeding fromflexible member 58. In the embodiments shown in FIG. 17 and FIG. 18,interior flexible member 58 is lined with a conductive spring 61 toserve as an electrode. A return electrode is also supplied. For example,base 54 can be made of a conductive material to serve as a returnelectrode.

As a further example of an equivalent structure that may be used toimplement the present invention, a rigid pivot arm 74 may haveextensions to permit more distal movement of interior flexible member58.

FIG. 19 shows an embodiment of pivot arm 74 with rotating extensions 127rotatably pinned to accommodate a design of pivot arm 74 that willaccordion as interior flexible member 58 is moved distally. FIG. 20shows the design of FIG. 19 in an extended position.

FIG. 21 shows a design of pivot arm 74 that has telescoping extensions129. FIG. 22 shows the design of FIG. 21 in an extended position.

It will become readily apparent that many other instruments may becreated to take advantage of configurations of pivot arm 74. Theseinstruments may, for example, provide injection therapy, irrigate theworksite, resect mucosa, and perform other useful functions fortreatment of body tissue. Interior forceps jaw 68 or exterior forcepsjaw 76 may become any interior end-effector or external end-effector forperforming useful work. Internal flexible member 58 and externalflexible member 64 may be any flexible members capable of maneuvering anend-effector, and each may have a handle for maneuvering and actuatingits respective end-effector. A first instrument having a first handle,an internal flexible member and an internal end-effector may then beinserted through instrument channel 42 of endoscope 14 and connected toan embodiment of pivot arm 74. A second instrument may be created havinga second handle, an external flexible member, and an externalend-effector. The first instrument may then be used cooperatively withthe second instrument inserted alongside endoscope 14 or through asecond instrument channel within endoscope 14 to perform therapy. It ispossible for instruments to be linked to become one instrument with twoend-effectors. The instrument created by linking may have one handlewith one actuation mechanism to activate both end-effectors.

FIG. 23 shows a first grasper 131 inserted through a first instrumentchannel 133 of a multi-channeled endoscope 141 having at least twoinstrument channels. First grasper 131 is connected to an embodiment ofpivot arm 74. First grasper 131 can cooperate with a second grasper 135inserted through a second instrument channel 137 to perform work ontissue distal to and on the periphery of multi-channeled endoscope 141.

FIG. 24 shows a first grasper 131 inserted through an instrument channel42 of an endoscope 14. First grasper 131 is connected to an embodimentof pivot arm 74. First grasper 131 can cooperate with a second grasper135 inserted alongside endoscope 14. Additional instruments may also beinserted to cooperate with first grasper 131.

The embodiments shown illustrate the use of the invention in connectionwith an endoscope within a body lumen. However, the invention is notlimited to use within a naturally occuring body lumen, but is alsouseful in a variety of minimally invasive medical procedures, includingwithout limitation medical procedures performed through laparoscopicincisions for access to body cavities and internal organs of the body.The invention also encompasses apparatus and methods employingendoscopic devices in general, including various forms and variations ofendoscopes, including without limitation: laparascopes, gastroscopes,peritoneoscopes, sigmoidoscopes, fiberoptic endoscopes, and the like.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. For example, as wouldbe apparent to those skilled in the art, the disclosures herein haveequal application in robotic-assisted surgery. In addition, it should beunderstood that every structure described above has a function and suchstructure can be referred to as a means for performing that function.Numerous variations, changes, and substitutions will now occur to thoseskilled in the art without departing from the invention. Accordingly, itis intended that the invention be limited only by the spirit and scopeof the appended claims.

1. An assembly for use in medical procedures, the assembly comprising: an endoscope having an instrument channel and a viewing element; a flexible instrument associated with the instrument channel; and an instrument guide pivotably sunported adjacent a distal end of the instrument channel, the instrument guide comprising two support members, the support members having onppsed ends adapted to engage the flexible instrument for guiding motion of a distal end of the instrument as a more proximal portion of the instrument is extended from the distal end of the endoscope, and wherein the instrument guide restricts twisting of the distal end of the instrument as a more proximal portion of the instrument is extended from the distal end of the endoscope.
 2. The assembly of claim 1 wherein the instrument guide provides bending of the instrument.
 3. The assembly of claim 2 wherein the instrument guide provides bending of the instrument through an angle of at least about 90 degrees.
 4. The assembly of claim 1 wherein the instrument guide constrains translational motion of an end of the instrument while permitting rotation of the end of the instrument about an axis that is not parallel to a longitudinal axis of the instrument channel.
 5. The assembly of claim 1 wherein the support members comprise curved portions shaped to avoid obstructing line of sight of the endoscope viewing element.
 6. The assembly apparatus of claim 1 wherein the instrument guide comprises a blade for cutting tissue.
 7. An assembly for use in medical procedures, the assembly comprising: an endoscope having an internally placed instrument channel, and a viewing element disposed at a distal end of the endoscope; a first instrument extending from a distal end of the instrument channel; and an instrument guide pivotably supported adjacent a distal end of the instrument channel; the instrument guide having opposed ends for constraining and guiding the position of the end of first instrument as the end of the first instrument is extended distally of the viewing element.
 8. The assembly of claim 7 wherein the first instrument comprises an electrode for providing tissue ablation.
 9. The assembly of claim 7 wherein the first instrument comprises a hollow member in communication with a source of vacuum.
 10. The assembly of claim 7 wherein the first instrument comprises a hollow member in communication with a source of argon plasma.
 11. The assembly of claim 7 wherein the first instrument comprises a blade for cutting tissue.
 12. The assembly of claim 7, further comprising a second instrument, wherein the instrument guide is adapted to engage the first instrument to manuever the first instrument to cooperate with the second instrument.
 13. The assembly of claim 7 further comprising means for suturing tissue.
 14. An assembly for use in medical procedures, the assembly comprising: an endoscope having an internally placed instrument channel and a viewing element disposed at the distal end of the endoscope; a flexible instrument extendable from a distal end of the instrument channel; and an instrument guide pivotably supported adjacent a distal end of the instrument channel, the instrument guide adapted for constraining and guiding the position of an end of the flexible instrument as the flexible instrument is extended from the instrument channel, wherein the instrument guide shaped to avoid obstructing line of sight of the viewing element.
 15. The assembly of claim 14 wherein the instrument guide provides bending of the flexible instrument.
 16. The assembly of claim 14 wherein the instrument guide provides bending of the instrument through an angle of at least about 90 degrees.
 17. The assembly of claim 14 wherein the instrument guide constrains translational motion of an end of the flexible instrument instrument while permitting rotation of the end of the instrument about an axis that is not parallel to a longitudinal axis of the instrument channel.
 18. The assembly of claim 14 wherein the instrument guide comprises a pair of support members having opposed distal ends for engaging the flexible instrument.
 19. The assembly of claim 18 wherein the instrument guide comprises a pair of curved support members.
 20. The assembly apparatus of claim 14 wherein the instrument guide comprises a blade for cutting tissue. 